IP Library Granted Patent US 12,409,169
Granted Patent B2
US 12,409,169 · App. 17/603,093 · Granted Sep 9, 2025

Composition comprising clay mineral complex for prevention, alleviation, and treatment of inflammatory bowel disease, preparation method for composition, and method for alleviation and treatment for inflammatory bowel disease

Inventors: Il-Mo Kang (Seoul, KR); Jangik Ike Lee (Seoul, KR); Dae-Duk Kim (Seoul, KR); Jae Hwan Kim (Pohang-si, KR); Ki-Min Roh (Daejeon, KR); Sung Man Seo (Pohang-si, KR); Su Young Jung (Seoul, KR); Ju-Hwan Park (Seoul, KR); Min-Jun Baek (Seoul, KR); Gyu-Ho Kim (Seoul, KR)
Assignee: Korea Institute Of Geoscience And Mineral Resources
A61K31/4353A61K9/0053A61K9/08A61K31/444A61K33/06A61K47/52A61P1/04A61P1/12A61P37/06
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Quick Facts
Patent No.
US 12,409,169
App. No.
17/603,093
Granted
Sep 9, 2025
Kind
B2
Abstract

The present invention relates to a pharmaceutical composition for prevention, alleviation, and treatment of inflammatory bowel disease, the composition comprising a complex of a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof and a clay mineral; a method for prevention, alleviation, and treatment of inflammatory bowel disease by using same; and a preparation method of the pharmaceutical composition.

Claims (23)

1. A pharmaceutical composition for treatment of inflammatory bowel disease, comprising a complex of a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof; and a clay mineral:

2. The pharmaceutical composition of claim 1 , wherein a time to reach maximum plasma concentration (t max ) during oral administration of the composition is 2 to 10 times longer than a time t max to reach maximum plasma concentration during oral administration of an aqueous solution of the compound of Chemical Formula 1.

3. The pharmaceutical composition of claim 1 , wherein a time to reach maximum plasma concentration (t max ) during oral administration of the composition is longer than a time to reach maximum plasma concentration (t max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

4. The pharmaceutical composition of claim 1 , wherein a maximum plasma concentration (C max ) during oral administration of the composition is 20% to 80% of a maximum plasma concentration (C max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

5. The pharmaceutical composition of claim 1 , wherein the maximum plasma concentration (C max ) during oral administration of the composition is lower than the maximum plasma concentration (C max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

6. The pharmaceutical composition of claim 1 , wherein an alleviation effect of a drug on a symptom selected from the group consisting of inflammation, crypt cell damage, ulcer, edema and fibrosis in a large intestine of the compound of Chemical Formula 1 during oral administration of the composition is higher than the alleviation effect of the drug in the large intestine during oral administration of an aqueous solution of the compound of Chemical Formula 1.

7. The pharmaceutical composition of claim 1 , wherein an absorption rate in a small intestine of the compound of Chemical Formula 1 during oral administration of the composition is lower than the absorption rate in the small intestine during oral administration of an aqueous solution of the compound of Chemical Formula 1.

8. The pharmaceutical composition of claim 1 , wherein a dissociation rate when the complex is added to an eluate of pH 1.2 is slower than the dissociation rate when the compound of Chemical Formula 1 is added to the eluate of pH 1.2.

9. The pharmaceutical composition of claim 1 , wherein a dissociation rate when the complex is added to an eluate of pH 7.4 is faster than the dissociation rate when the compound of Chemical Formula 1 is added to the eluate of pH 7.4.

10. A preparation method of a pharmaceutical composition for treatment of inflammatory bowel disease, comprising preparing a complex by mixing a solution containing a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof, an acidic reaction solution, and a clay mineral suspension to adsorb the compound onto the clay mineral:

11. The preparation method of the pharmaceutical composition of claim 10 , wherein the pH of the reaction solution is pH 0.5 to pH 3.5.

12. A food composition for alleviation of inflammatory bowel disease, comprising a complex of a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof; and a clay mineral:

13. A method for treatment of inflammatory bowel disease, comprising administering a pharmaceutical composition including a complex of a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof; and a clay mineral to a subject in need thereof:

14. A method for alleviation of inflammatory bowel disease, comprising administering a pharmaceutical composition including a complex of a compound of Chemical Formula 1 or a pharmaceutically acceptable salt thereof; and a clay mineral to a subject in need thereof:

15. The method for treatment of inflammatory bowel disease of claim 13 , wherein a time to reach maximum plasma concentration (t max ) during oral administration of the composition is 2 to 10 times longer than a time to reach maximum plasma concentration (t max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

16. The method for treatment of inflammatory bowel disease of claim 13 , wherein a time to reach maximum plasma concentration (t max ) during oral administration of the composition is longer than a time to reach maximum plasma concentration (t max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

17. The method for treatment of inflammatory bowel disease of claim 13 , wherein a maximum plasma concentration (C max ) during oral administration of the composition is 20% to 80% of a maximum plasma concentration (C max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

18. The method for treatment of inflammatory bowel disease of claim 13 , wherein the maximum plasma concentration (C max ) during oral administration of the composition is lower than the maximum plasma concentration (C max ) during oral administration of an aqueous solution of the compound of Chemical Formula 1.

19. The method for treatment of inflammatory bowel disease of claim 13 , wherein an alleviation effect of a drug on a symptom selected from the group consisting of inflammation, crypt cell damage, ulcer, edema and fibrosis in a large intestine of the compound of Chemical Formula 1 during oral administration of the composition is higher than the alleviation effect of the drug in the large intestine during oral administration of an aqueous solution of the compound of Chemical Formula 1.

20. The method for treatment of inflammatory bowel disease of claim 13 , wherein an absorption rate in a small intestine of the compound of Chemical Formula 1 during oral administration of the composition is lower than the absorption rate in the small intestine during oral administration of an aqueous solution of the compound of Chemical Formula 1.

21. The method for treatment of inflammatory bowel disease of claim 13 , wherein a dissociation rate when the complex is added to an eluate of pH 1.2 is slower than the dissociation rate when the compound of Chemical Formula 1 is added to the eluate of pH 1.2.

22. The method for treatment of inflammatory bowel disease of claim 13 , wherein a dissociation rate when the complex is added to an eluate of pH 7.4 is faster than the dissociation rate when the compound of Chemical Formula 1 is added to the eluate of pH 7.4.

23. The method for treatment of inflammatory bowel disease of claim 13 , wherein the inflammatory bowel disease is Crohn's disease or ulcerative colitis.

Assignments (2)
CORRECTIVE ASSIGNMENT TO CORRECT THE ASSIGNEE NAME PREVIOUSLY RECORDED ON REEL 58048 FRAME 992. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Jul 11, 2025
From: KANG, IL-MO; LEE, JANGIK IKE; KIM, DAE-DUK; KIM, JAE HWAN; ROH, KI-MIN; SEO, SUNG MAN; JUNG, SU YOUNG; PARK, JU-HWAN; BAEK, MIN-JUN; KIM, GYU-HO
To: KOREA INSTITUTE OF GEOSCIENCE AND MINERAL RESOURCES
Reel/Frame 072412/0523 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 8, 2021
From: KANG, IL-MO; LEE, JANGIK IKE; KIM, DAE-DUK; KIM, JAE HWAN; ROH, KI-MIN; SEO, SUNG MAN; JUNG, SU YOUNG; PARK, JU-HWAN; BAEK, MIN-JUN; KIM, GYU-HO
To: KOREA INSTITUTE OF GEOSCIENCE AND MINIERAL RESOURCES
Reel/Frame 058048/0992 →
Priority Claims (1)
KR 10-2019-0043172 · Apr 12, 2019 · national
Continuity (1)
Related Publication 20220193049A1 · Jun 23, 2022
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